Quality engineer

job summary:
Accelerate your career in medical device quality assurance and compliance by stepping into a crucial Quality Engineer role. You will join an active, 16-member team supporting high-priority QMS remediation, gap analysis, and supplier quality management initiatives directly ahead of upcoming regulatory audits. This position offers uncompromised, hands-on exposure to medical device regulations and collaborative mentorship under senior and principal engineers.

The role operates out of a highly collaborative manufacturing and engineering facility situated in Warrendale, PA. This fully onsite workspace connects you directly with cross-functional departments and global quality teams, facilitating seamless document routing, project management, and daily technical operations.

location: Warrendale, Pennsylvania
job type: Contract
salary: $75.00 - 82.76 per hour
work hours: 9 to 5
education: Bachelors


responsibilities:

• Support the supplier quality team by managing compliance documentation for roughly 200 suppliers.
• Manage supplier outreach, gather and track required files, and secure final compliance approvals.
• Assist principal engineers in authoring, revising, and updating QMS procedures and Technical Services SOPs.
• Navigate and utilize internal document control systems to route changes for approval.
• Review, track, and categorize existing CAPA records by risk level (High, Medium, Low).
• Develop compliance \"storyboards\" for critical CAPAs using templates to prepare for FDA inspections.
• Track CAPA milestones, manage project timelines, and flag major compliance risks to leadership.

qualifications:
Required Skills:

• Bachelor's Degree in a science or engineering field.
• Experience with supplier file management and basic supplier compliance interactions.
• Hands-on SOP and work instruction (WI) technical writing and editing experience.
• Basic project management, CAPA execution, and timeline tracking experience.

Preferred Skills:

• 1-3 years of post-bachelor's experience in a medical device or highly regulated manufacturing environment (e.g., aerospace, nuclear, pharma).
• Proficiency with MS Project, Gantt trackers, or general project management tools.
• Knowledge of quality systems requirements (21 CFR Part 820, ISO 13485, or MDSAP).
• Experience with V&V (Verification & Validation) review, training creation, and data entry.

#LI-ST1

skills: MS-EXCEL, Corrective and Preventive Actions (CAPA), Quality Assurance (QA)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on click.appcast.io.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.